Active — Not RecruitingPhase 1/2

Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases

Brazil30 participantsStarted 2024-03-01

Plain-language summary

This prospective, comparative pilot study investigates the safety and functional outcomes of intravitreal adalimumab (ADA) in patients with Retinitis Pigmentosa (RP) and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP). Participants will receive three intravitreal injections of adalimumab (2 mg/0.05 mL) at two-month intervals (M0, M2, M4). The primary objective is to assess functional changes after 6 months, focusing on visual-field preservation (Field Preservation Deviation Index - FPDI, Mean Deviation - MD) and best-corrected visual acuity (LogMAR). Secondary outcomes include alterations in 30-Hz flicker ERG amplitude, OCT parameters (central macular thickness and ellipsoid zone length), and ocular safety measures such as intraocular pressure and inflammatory response.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Age ≥ 18 years. * Clinical diagnosis of retinitis pigmentosa (RP) or EMAP (Extensive Macular Atrophy with Pseudodrusen-like Appearance) confirmed by multimodal evaluation. * Best-corrected visual acuity (BCVA) ≥ counting fingers at 1 meter (approximately ≤ 1.9 logMAR) in the study eye. * Measurable visual field on iCare COMPASS (10-2 or 24-2) with acceptable reliability indices. * Clear ocular media adequate for safe intravitreal injection and high-quality OCT imaging. * Ability and willingness to provide written informed consent. * Ability to comply with scheduled study visits (Baseline \[M0\], Day 7-14 after injections, Month 2 \[M2\], Day 7-14, Month 4 \[M4\], Day 7-14, and Month 6 \[M6\]). * For ERG subset only: presence of a recordable baseline 30-Hz flicker ERG response (signal-to-noise ratio ≥ 3:1 and amplitude ≥ 3.0 µV). * Note: Absence of a measurable flicker ERG response does not exclude participation in the main study. Exclusion Criteria: * Active ocular inflammation (anterior, intermediate, or posterior uveitis) or infectious ocular disease in the study eye. * Active choroidal neovascularization or other macular diseases unrelated to RP or EMAP. * Uncontrolled glaucoma (intraocular pressure \> 21 mmHg despite therapy) or optic neuropathies not related to RP or EMAP. * Significant media opacity that may impair imaging quality or safe intravitreal injection. * Recent ocular interventions that may confound study outcomes, including: * Intravit…

What they're measuring

Change in Field Preservation Deviation Index (FPDI)

Timeframe: Baseline to Month 6

Change in Mean Deviation (MD)

Timeframe: Baseline to Month 6

Change in Best-Corrected Visual Acuity (BCVA)

Timeframe: Baseline to Month 6

Trial details

NCT IDNCT07348588

SponsorCentro de Pesquisa Rubens Siqueira

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Retinitis Pigmentosa (RP) trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.